FDA Roundup: Apple AirPods Hearing Aids, Tremfya for Ulcerative Colitis
Check out important updates from the FDA for the week of August 9.
FDA Approves OTC Hearing Aid Software for Apple AirPods
FDA Roundup: Apple AirPods Hearing Aids, Tremfya for Ulcerative Colitis / Tada Images - stock.adobe.com
The FDA approved new over-the-counter hearing aid software that is compatible with certain versions of Apple’s AirPods Pro headphones, the federal agency announced in a release.1 The software-only mobile medical application, called Hearing Aid Feature, is intended for adult use and can be customized to an individual’s hearing needs.
The approval of the hearing aid software was based on a clinical study that included 118 adults with perceived mild to moderate hearing loss. The study showed that participants who used the software had comparable performance compared to professional fitting hearing aids for tests measuring levels of amplification in the ear canal and a measure of speech understanding in noise. There were no adverse events observed in the study.
“Hearing loss is a significant public health issue impacting millions of Americans,” Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health, said in a release.1 “[This] marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
FDA Approves Tremfya for Treatment of Active Ulcerative Colitis
The FDA approved guselkumab (Tremfya) for the treatment of moderate to severe active ulcerative colitis in adults patients, Johnson & Johnson announced in a release.2 The approval marks the third indication for Tremfya, which is also approved to treat adult patients with moderate to severe plaque psoriasis and adults with active psoriatic arthritis.
The approval was based on data from the ongoing Phase 2b/3 QUASAR study, which is evaluating the efficacy and safety of Tremfya in adult patients with moderately to severely active ulcerative colitis who experienced an inadequate response or who demonstrate intolerance to conventional therapy, other biologics and/or JAK inhibitors. The study showed that 50% of patients who received 200 mg of the therapy every 4 weeks and 45% who received 100 mg every 8 weeks achieved the primary endpoint of clinical remission at week 44.
“Treatment with Tremfya resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining,” David T. Rubin, MD, director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, said in a release.2 “[This] approval of Tremfya builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease.”
Plozasiran Receives FDA Breakthrough Therapy Designation
Arrowhead Pharmaceuticals announced the FDA granted breakthrough therapy designation to plozasiran, an investigational therapy for use as an adjunct to diet to reduce triglycerides in adult patients with familial chylomicronemia syndrome (FCS). There are currently no approved treatments for the rare genetic disease in the United States.
Plozasiran is a first-in-class investigational RNA interference (RNAi) therapy designed to reduce production of apolipoprotein C-III (APOC3). The therapy has demonstrated reductions in both triglycerides and multiple atherogenic lipoproteins in several clinical studies. It has also shown to have a favorable safety profile. It was previously granted orphan drug and fast track designations. Arrowhead said in the release that it intends to file a new drug application with the FDA sometime this year.
“There are currently no FDA-approved therapies to specifically treat FCS, leaving physicians with very few options to help their patients,” Chris Anzalone, PhD, president and CEO of Arrowhead., said in a release.3 “Results from clinical studies of investigational plozasiran have been highly encouraging and strongly supportive of further development and commercialization in multiple patient populations. Receiving FDA Breakthrough Therapy designation for plozasiran provides important benefits and the potential to expedite the process of getting plozasiran to the patients who need it.”
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